MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the proximal end of left anterior descending artery.A 2.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during inflation upon reaching the rated burst pressure, the balloon ruptured.The procedue was completed with another of same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was contrast present in the inflation lumen and blood in the guidewire lumen.The balloon has a 5mm longitudinal tear in the balloon 6mm from the tip of the device.The device also has tip damage.Product analysis confirmed the reported event, as there was a longitudinal tear in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the proximal end of left anterior descending artery.A 2.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during inflation upon reaching the rated burst pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11795082
• Report Number: 2134265-2021-05994
• Device Sequence Number: 3972257
• Product Code: LOX
• UDI-Device Identifier: 08714729392637
• UDI-Public: 08714729392637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0025493688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 56